Kornimate/medical-research-clean huggingface dataset:
silodosin in retrograde intrarenal surgery

Conditions: Urolithiasis

Summary: selective alpha-blockers have been used for the treatment of ureteric stones as medical expulsive therapy (met). recently they have been successfully used in passive ureteric dilatation before semirigid ureteroscopy. this study enables us to know the role of silodosin in ureteric dilatation to facilitate ureteral access sheath placement in retrograde intrarenal surgery with flexible ureteroscopy.

the ureteral access sheaths (uas) used during retrograde intrarenal surgery (rirs) were produced for easy access to the upper urinary tract. the main advantages of uas are providing repetitive access to the ureteral and collecting duct system, decreasing intrarenal pressure, preventing bleeding-related distortion of vision by the acceleration of liquid flow, and eventually contributing toward the protection of the flexible device. nevertheless, there might be certain challenges during uas placement. there are also risks, such as ureteral injury and the occurrence of ureteral stricture in the long term. however, considering the benefit/risk balance, rirs is routinely performed in many clinics because of the ease provided by uas. some problems might occur during the placement of uas whose diameters vary between 9.5 and 14 fr. in cases where uas cannot be placed, manipulations can be used, such as ureteral balloon dilatation, providing access through a rigid ureteroscope with a guide wire, or dilatation with the inner sheath of the uas, which may vary depending on the amount of personal experience. despite such manipulations, if uas placement is still unsuccessful, it is always more logical to place a double-j stent, enables passive dilatation, and postpone rirs until the second operation. this study will examine whether intramural ureteral resistance can be reduced or not and whether uas placement can be facilitated using silodosin or not.

Eligibility criteria:
inclusion criteria: * both sex. * age \>18 yrs old. * upper ureteric stones or renal stones \< 2 cm. * patients with normal renal anatomy. * no history of infectious or inflammatory renal condition. exclusion criteria: * • \< 18 years old. * multiple or bilateral stones. * pregnant women. * ureteric strictures. * urinary tract infection. * coagulopathy and uncorrected bleeding disorders. * refusal of the surgery and requiring stent.
20- versus 23- gauge system for pars plana vitrectomy

Conditions: Diabetic Retinopathy; Macular Edema; Postoperative Complications; Vitreous Hemorrhage

Summary: the aim of the present study is to compare the functional and clinical differences and advantages between a standard operating system and a newly developed even smaller system for pars plana vitrectomy. the present study may work out the possible advantages and disadvantages between the routinely used 20-gauge vitrectomy system and the newly developed 23-gauge device.

60 patient randomized into 2 groups of 30 each. all of them operated in general anesthesia, vitrectomized and cataract extracted by phacoemulsification if indicated. preoperative and postoper5ative controls at days 1,2,3 and week 1, month 1,3 and 12 performed. parameters of interest are: postoperative conjunctival injection, pain, eye pressure, complications intra- and postoperative as well as the durations of surgery divided into opening time, vitrectomy time, retinal manipulation time, closing time.

Eligibility criteria:
inclusion criteria: * over 18 years of age * written form of consent * vitreous and retinal pathologies requiring surgery exclusion criteria: * previous history of vitreous or retinal surgery * pregnant or breastfeeding women * prohibiting general medical conditions or diseases * no informed consent signed * under 18 years of age

Keywords: 23 gauge pars plana vitrectomy conjunctival erythema and injection 20 gauge pars plana vitrectomy vitreous and retinal surgery
efficacy of provex cv supplement to reduce inflammation cytokines and blood pressure

Conditions: Blood Pressure

Summary: the purpose of this study is to determine if a supplement called provex cv can reduce blood pressure and other risk factors for heart disease. heart disease is the leading cause of death in this country and it is important to identify dietary factors, including supplements, that can reduce heart disease risk factors. the supplement to be tested in this study is made of a combination of natural compounds found in plants such as grapeseed extract, green tea, and quercetin. each compound individually has been shown to improve blood pressure or reduce inflammation. we hypothesize that provex cv will reduce blood pressure and levels of inflammatory cytokines hypertensive patients with symptoms of metabolic syndrome. this investigational trial of provex cv has been approved by the united states food and drug administration.


Eligibility criteria:
inclusion criteria: * males (18 - 65) and postmenopausal females (up to age 65) with metabolic syndrome who have stage 1 hypertension. * since all subjects will have stage 1 hypertension, they must also meet at least 2 of the following criteria of metabolic syndrome to qualify for the study; waist circumference of \>35 inches for women or \>40 inches in men, fasting plasma triglycerides of \>150 mg/dl, fasting glucose of \>100 mg/dl, hdl of \<40 in men. pre-hypertension or greater (130 + mm hg systolic/80+mm hg diastolic) is defined by the 7th report for the joint national committee on prevention, detection, evaluation, and treatment of high blood pressure. exclusion criteria: * subjects who are allergic to tea or grapes (on which the supplement is based). * participants who have blood pressure less than 130 mmhg / 80 mmhg, * have a history of a prior cardiovascular event, diabetes, pregnancy, liver disease, renal insufficiency, any chronic disease that might interfere with study participation, * bmi above 40 kg/m2, * consumption of \>12 alcoholic drinks weekly, * unwillingness to stop current supplement intake or use of calcium/ magnesium antacids.
a study on the safety of deucravacitinib exposure in pregnant women and their offspring

Conditions: Psoriasis

Summary: this observational study aims to assess pregnancy and infant outcomes among pregnant women with psoriasis who have been exposed to deucravacitinib treatment in the usa.


Eligibility criteria:
inclusion criteria: * maternal age 15 through 50 years at date of conception * start of pregnancy, defined as the estimated date of conception, during the accrual period (09-sep-2022 through 31-oct-2026) * continuous medical and pharmacy coverage for a minimum of 6 months prior to and including the estimated date of conception * presence of psoriasis from 12 months prior to the date of conception through the end of pregnancy exclusion criteria: • exposure to any known teratogens from 5 half-lives prior to the estimated date of conception through the end of the relevant exposure window

Keywords: psoriasis
effect of therapeutical paraffin in the malleability of burned skin

Conditions: Burn

Summary: effect of therapeutical paraffin wax bath in the malleability of burned skin

the altered biomechanical properties of the skin entail limitation of movement, it have been important the statement of resources aimed at increasing skin suppleness. the objective of the study is to evaluate the effect of therapeutic paraffin in biophysical characteristics of the burned skin with or without scar hypertrophic. for this, 60 volunteers will be evaluated in the age group of 18-60 years, of both sexes, with deep second degree and third degree burns and evaluated areas submitted to therapeutic procedures, divided evenly into scar areas and normal skin. applications will be set randomly by lot, with cross design (cross-over), and a minimum interval of seven days (wash-out) of the activities. the biophysical and biomechanical parameters of the skin will be assessed noninvasively by cutometer of the model (mpa) 580, device to measure elasticity of the upper skin layer using negative pressure, and the durometer, measure hardness of the skin, before, immediately after 0, 10, 20 and 30 minutes of intervention with therapeutic paraffin in different procedures (number of layers and thermal insulation). sociodemographic, clinical and surgical data of the volunteers will be evaluated by spss 15 (statistical analysis software). the normality of the data will be verified by the shapiro-wilk test, and the effect of therapeutic procedures over time evaluated by the friedman test (intragroup) and the test kruskal-wallis post hoc dunn for comparisons between different funds (intergroup), p \<0.05, will evaluated by software spss.

Eligibility criteria:
inclusion criteria: * will be included in the study individuals who were victims of 2 deep burns or 3rd grade being subjected to grafting autogenous procedures, with or without the presence of hypertrophic scar, normal skin of individuals, ie without tissue damage and to agree to sign the term free and informed consent. exclusion criteria: * they will be included in this study individuals with diseases or deformities that affect the structure and function of the skin.

Keywords: physiotherapy paraffin burn contracture
randomized study on efficacy of gemifloxacin-based regimen for helicobacter pylori infection

Conditions: Helicobacter Pylori Infection

Summary: new generations of fluoroquinolones, like levofloxacin and moxifloxacin, exhibit a broad-spectrum activity against gram-positive and gram-negative bacteria, and have been successfully introduced into the treatment of helicobacter pylori infection. however, it was suggested that resistance to fluoroquinolones has been increasing in the korean population and the resistance is most likely mediated through point mutation in gyra. gemifloxacin (factive®) is an enhanced-affinity, broad-spectrum fluoroquinolone suitable for once-daily, oral dosing. in vitro studies have shown that gemifloxacin displays potent activity against gram-positive organisms, whilst retaining good activity against gram-negative organisms. gemifloxacin is the most potent member of the quinolone class against s. pneumoniae with activities 16-64 times greater than those of ciprofloxacin and ofloxacin and 2-8 times greater than those of moxifloxacin. importantly, gemifloxacin displays potent in vitro activity against strains of s. pneumoniae with known resistance to β-lactams, macrolides and other members of the quinolone class. this potent activity is believed to be due to the enhanced affinity of gemifloxacin for topoisomerase iv, the major fluoroquinolone target in s. pneumoniae. furthermore, gemifloxacin displays potent activity against h. influenzae and m. catarrhalis and atypical organisms such as l. pneumophila, c. pneumoniae and m. pneumoniae. it has proven particularly effective in respiratory and urinary tract infection.

the purpose of this study is to compare the efficacy and the safety of using standard triple therapy and gemifloxacin-containing triple therapy as a first-line treatment for helicobacter pylori eradication in korea.

Eligibility criteria:
inclusion criteria: * patients aged 19-70 years with h. pylori infection * the presence of h. pylori was defined as positive if the results of one of the following two tests were positive: 1. rapid urease test (clo™, delta west, bentley, western austria) 2. histology. biopsy specimens, obtained by endoscopy, were fixed in formalin and used for determination of h. pylori infection by giemsa staining. exclusion criteria: 1. patients with previous h. pylori eradication therapy 2. patients treated with h2 receptor antagonist, ppi, and antibiotics in the previous 4 weeks, or nonsteroidal anti-inflammatory drug (nsaid) in the previous 2 weeks 3. pregnant or lactating women 4. patients who suffered from serious diseases such as severe liver disease, renal disease, and cerebrovascular disease 5. patients who had a drug allergy to the study drugs 6. patients with previous gastric surgery.
human factors study to validate the user interface of tobi podhaler using placebo capsules

Conditions: Cystic Fibrosis

Summary: the purpose of this study is to validate the user interface of tobi podhaler by establishing that the product can support safe and effective use for the intended users

the objective is to conduct a human factors validation study to demonstrate that the user interface of tobi® podhaler™ can support safe and effective use for the intended users. the human factors validation study will be conducted in patients with cystic fibrosis aged 6 years and older under simulated yet representative of realistic use conditions where patients with no prior training or use of tobi® podhaler™ will be asked to inhale the contents of placebo capsules through the podhaler device. due to the use of placebo capsules, the study is considered an interventional clinical study and will be conducted accordingly. the study is an open label, un-blinded, non-randomized study which consists of one visit.

Eligibility criteria:
inclusion criteria: * written informed consent or, parent/guardian consent and where applicable pediatric assent, must be obtained before any assessment is performed * male and female subjects aged 6 years and older * confirmed diagnosis of cf by one or more of the following tests for cf as documented in the patient's medical history : (1) quantitative pilocarpine iontophoresis sweat chloride test of \> 60 mmol/l or 60 meq/l, (2) genotype with identifiable cf-causing mutations on both chromosomes, (3) an abnormal nasal transepithelial potential difference characteristic of cf * fev1 value must be at least 25% of normal predicted values for age, sex, and height as documented in the patient's medical history (historical values within 3 months can be used for this criterion). * able to comply with all protocol requirements * clinically stable in the opinion of the investigator exclusion criteria: * subjects currently enrolled in studies that are not considered as observational non-investigational studies * subjects or caregivers who have used the podhaler device previously * hemoptysis more than approximately 60 ml at any time within 30 days prior to enrollment * history of hypersensitivity to the inhaled placebo dry powder (dspc and/or calcium chloride powder) * signs and symptoms of acute pulmonary disease, e.g. pneumonia, pneumothorax, bronchospasm, acute respiratory infection * clinically significant conditions or findings at enrollment that might interfere with the accurate and valid assessment of this study * subjects or caregivers who are considered potentially unreliable or considered unlikely to be compliant within the trial * pregnant women

Keywords: cf, human factors, tobi® podhaler™, user interface, ifu
hasan kalyoncu university

Conditions: Aggression; Forensic Psychiatric Patients

Summary: aggression is a serious problem that appears to be common in forensic psychiatric patients. determining factors related to aggression is important for psychiatric nurses during the treatment, care and rehabilitation of patients. the aim of this study is to determine the relationship between childhood traumas, cognitive distortions and aggression in forensic psychiatry patients. this descriptive study was conducted with 103 male forensic psychiatry patients treated in a high security forensic psychiatry hospital. the data of study were collected introductory information form, childhood psychological traumas scale (ctq), cognitive distortions scale (cds) and buss-perry aggression scale (baq). in this study, 82.5% of forensic psychiatry patients were male, 50.5% were married, 49.5% had secondary education, 53.4% were not working. it was found that patients diagnosed with schizophrenia spectrum and other psychotic disordersa and bipolar affective disorders, who were hospitalised more than 5 times, who used alcohol/substances and who had previous experience of forensic events had higher levels of aggression. there was a significant positive correlation between the childhood traumas, cognitive distortions and aggression. the results of this study reveal important results that will contribute to psychiatric nurses caring for forensic psychiatric patients in determining the patients' aggression and affecting factors during the treatment and care process.


Eligibility criteria:
inclusion criteria: * people who do not have criminal liability * do not have a reading comprehension problem * volunteers to participate in the research exclusion criteria: * patients who did not agree to participate in the study or who left the study

Keywords: forensic psychiatric patients aggression childhood traumas cognitive distortions nursing
characteristics of rheumatoid arthritis patients with atlantoaxial synovitis detected by plain x-ray and mri

Conditions: Neck Pain

Summary: this study detects the presence of atlantoaxial joint affection in symptomatic versus asymptomatic rheumatoid arthritis patients revealed by plain x-ray and magnetic resonance imaging of the cervical spine

atlantoaxial joint affection in rheumatoid arthritis patients may have life-threatening complications if not detected early. it may not be detected unless it becomes symptomatic. however, asymptomatic atlantoaxial joint affection is not uncommon. investigators will try to detect atlantoaxial joint affection at an early stage and its relation to symptomatology and other disease criteria. so investigators will use conventional plain x-ray examination combined with magnetic resonance imaging of the cervical spine to detect soft tissue as well as bony changes of this condition.

Eligibility criteria:
inclusion criteria: * rheumatoid arthritis patients complaining or not complaining of atlantoaxial affection symptomatology exclusion criteria: * pregnant females * patients with pacemakers or metallic bony plates. * patients that have claustrophobia

Keywords: aaj ra mri synovitis
case series with saneso 3600 colonoscope

Conditions: Colonic Neoplasms

Summary: saneso colonoscope is a novel fda cleared colonoscope that provides a 360 degree integrated view of the colon. saneso colonoscope has five cameras and multiple led lights at the distal head. the objective of the present study is to evaluate clinical success of the saneso colonoscope in intubation of the terminal ileum and to obtain user feedback with regards to usability characteristics compared to predicate devices.

this study is a prospective, multi-center case series of per standard of care colonoscopy procedures using a nonsignificant risk saneso 360 degree colonoscope. 40 cases were included at 3 clinical sites. patients who meet all eligibility criteria were included and had a clinically indicated colonoscopy procedure performed using the study device. immediately thereafter, patients had a colonoscopy procedure using standard colonoscope (olympus cf 180) by a second endoscopist. enrolled subjects were followed for 7 days after their procedure. if the procedure was not successful with the study device, the endoscopist completed the procedure with a traditional colonoscope used at each facility. this study was approved by the institutional review board of respective sites. the clinical trial was conducted in accordance with the standards of good clinical practice (gcp) and in accordance with the principles of the declaration of helsinki.

Eligibility criteria:
inclusion criteria: * 45 -74 years of age willing and able to comply with the study procedures and provide written informed consent to participate in the study. scheduled for a clinically indicated routine colonoscopy procedure asa class 1-3. exclusion criteria: * altered colon anatomy pregnant women, children under 18 years of age and adults over 75 years of age. subjects for whom routine endoscopic procedures are contraindicated due to comorbid medical conditions. patients who are currently enrolled in another investigational study that would directly interfere with the current study, without prior written approval from the sponsor asa class 4-5.

Keywords: colonoscopy colonoscope
radiation therapy (hb-001) by alpha-particle sources for recurrent malignant solid tumors in japan

Conditions: Breast Cancer; Head and Neck Cancer

Summary: an intratumoral alpha particle based approach for cancer treatment using diffusion alpha-emitting radiation therapy (dart)

this will be a prospective, open label, single arm, controlled study, assessing the safety and efficacy of diffusing alpha emitters radiation therapy (dart) delivered through radioactive seeds inserted into the tumor. this approach combines the advantages of local intratumoral irradiation of the tumor, as used in conventional brachytherapy, with the power of the alpha radiation emitting atoms, that will be introduced in quantities considerably lower than radiation therapy already used in patients. superficial lesions with histopathological confirmation of malignancy will be treated using dart seeds. reduction in tumor size 70 days after dart insertion will be assessed. safety will be assessed by the incidence, severity and frequency of all adverse events (ae).

Eligibility criteria:
inclusion criteria: 1. head and neck cancer or breast cancer patients with histopathological proven malignancies who have a history of radiation therapy and who have been diagnosed with refractory malignancies with or without medical treatment. 2. tumor size is 5 cm or less in the longest diameter 3. age 18 years or older 4. eastern cooperative oncology group performance status is 2 or less 5. life expectancy: 6 months or longer 6. vital signs (systolic and diastolic blood pressure, pulse rate, body temperature, and respiratory rate) are stable 7. platelet count \>= 100,000/mm3 and prothrombin time prothrombin time-international normalized ratio \<= 1.8 8. women of childbearing potential have to be confirmed not pregnant by a pregnancy test and have to agree to prevent conception throughout the study. 9. having received explanation about the study, consented to participate in the study and signed the informed consent form. 10. measurable disease according to recist v1.1 exclusion criteria: 1. the size of the tumor more than 5 cm in the maximum diameter. 2. ecog performance status is 3 or higher 3. continuously receiving medication that may have a significant impact on the evaluation of safety or efficacy, such as immunosuppressants and/or corticosteroids. 4. history of serious allergy to the medicine for the treatments like anesthesia. 5. there are tumors to be preferentially treated such as metastatic lesion other than the target tumor 6. having received chemotherapeutic drugs (except hormonal agents), immunotherapeutic agents, and molecular targeting agents in the past 30 days, which may affect the assessment of the safety or efficacy of the hb-001 brachytherapy. 7. having received immune checkpoint inhibitor in the past 2 months, which may affect the assessment of the safety or efficacy of the hb-001 brachytherapy. 8. having participated in different clinical studies in the past 30 days, which may affect the assessment of the safety or efficacy of hb-001 brachytherapy 9. pregnant women or breast-feeding mothers 10. those who do not wish to sign the informed consent form